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DELIVERED IN PARTNERSHIP WITH CPI
A UK CENTRE OF EXCELLENCE FOR THE BIOSCIENCE INDUSTRY TRAINING
YARM ROAD
B6275
DARLINGTON TOWN CENTRE
HAUGHTON ROAD
A68 A167
A1(M)
A66
A66(M)
A1150
VIRAL VECTORS MANUFACTURING
CAG
1200
1
National Horizons CentreDarlingtonDL1 1HG
T: 01642 738777E: [email protected]
A66
Module one: An introduction to cell culture based viral vector production
This module provides an introduction to viral vector production, with a focus on upstream processing, as well as a basic introduction to GMP manufacture.
Delegates will have the opportunity to tour the NHC and CPI’s National Biologics Manufacturing Centre including a tutorial on iCELLis® for adherent production and STR for suspension cultures.
> Session one: An introduction to Cell and Gene Therapy. > Session two: Viral vector production modes: transient
transfection versus stable producer cell systems and adherent versus suspension culture systems.
> Session three: An introduction to GMP manufacture.
Module two: Transfection of cells for AAV production
This module introduces transient transfection and explains and how and why it is used for AAV production. The module will be a combination of talks, case studies and a practical session to demonstrate PEI-mediated transfection of suspension cells cultured at shake flask scale.
> Session one: An introduction to transfection. > Session two: Transfection for AAV production. > Session three: The optimisation and scale up of AAV
production.> Session four: Lab demonstration and practical.
Module three: Harvest and purification of AAV
This module gives an overview of a typical downstream purification process for viral vector gene therapy products including primary clarification, concentration, and chromatography steps. It explores the current challenges for the purification of viral vectors.
> Session one: Product specific features important for viral vector purification.
> Session two: Cell harvesting and viral vector recovery from cells.
> Session three: Chromatographic approaches to purification including new affinity chromatography and new non-beaded formats.
> Session four: High resolution separation for empty versus full capsid separation.
> Session five: Paper-based practical .
VIRAL VECTORS MANUFACTURING02 TRAINING 03
WELCOME
As a National Training Centre for Advanced Therapies, funded from the Department for Business, Energy & Industrial Strategy (BEIS) and Innovate UK (IUK) delivered through the Cell and Gene Therapy Catapult, our courses are industry approved and we have worked closely with key bioindustry leaders across the sector to ensure our courses have been designed to deliver vital skills needed for advanced therapies, vaccines manufacturing and bioprocessing.
Welcome to the National Horizons Centre (NHC). We are Teesside University’s centre of excellence for the biosciences and healthcare sector. With research, partnerships and training at our core, we bring together industry, academia, talent and world-class facilities to create real-world impact.
Dr Jen VanderhovenDIRECTOR
Module four: Analytical methods for viral vector characterisation
This module introduces the analytical requirements for viral vectors and gives an overview of the analytical toolbox used for product characterisation, including titre (particle, genomic and infectious), purity and aggregation.
> Session one: Introduction to viral vector analysis and discussion on the complexity of viral vector characterisation.
> Session two: Overview of current analytics for the analysis of titre, including particle titre, genomic titre and infectious titre.
> Session three: Analytical methods for assessing process related impurities during manufacture.
> Session four: Analytical methods for assessing process and product related impurities during manufacture, plus an introduction to assessment of Critical Quality Attributes (CQA) in viral vectors.
> Session five: Basic mass spectrometry and UPLC based techniques for viral vector characterisation and residual solvents.
> Session six: Demonstration of ELISA analysis for particle titre determination, qPCR for genomic titre determination and use of the Uncle system (Unchained Labs) for assessing capsid stability and aggregation.
Module five: Viral vectors manufacturing workshop
> Experiment: ELISA for host cell proteinsThis module allows delegates to put learning into practice through a case study. Delegates will create a plan for the development and GMP manufacture of a new gene therapy product for IND submission and Phase I clinical trials. This plan will be presented to the rest of the group in a quick 5-10 minute presentation.
COURSE OVERVIEW
Delivered in partnership with the Centre for Process Innovation, our Viral Vectors Manufacturing training course covers the production of viral vectors, their optimisation and scale-up. Our unique training facility houses state-of-the-art equipment that provides delegates with the opportunity to gain hands-on practical training in complex bioprocessing procedures.
I look forward to welcoming you to the NHC.
The NHC is one of the National Training Centres part of the ATSTN programme funded from the Department for Business, Energy & Industrial Strategy (BEIS) and Innovate UK (IUK) delivered through the Cell and Gene Therapy Catapult.
